PROPPER SUPER SERACULT(R)
FDA 510(k) clearance K921798 · decided 1992-10-05
Clearance details
- K-number
- K921798
- Device name
- PROPPER SUPER SERACULT(R)
- Applicant
- Propper Mfg. Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-14
- Decision date
- 1992-10-05
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- KHE
- Device class
- 2
- Regulation number
- 864.6550
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Long Island City, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.